Scalp Blocks Effect on Postoperative Nausea & Vomiting After Craniotomy

NCT ID: NCT04240236

Last Updated: 2020-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-30
• Study Completion Date: 2020-07-01

Brief Summary

In this study, the investigators hypothesize that preemptive scalp block in neurosurgical patients may decrease incidence of PONV after craniotomy through decreasing intraoperative inhalational agents' concentration and decreasing intraoperative opioids requirements, with better intraoperative hemodynamics and lesser recovery time

Detailed Description

Patients will be recruited after admission to the hospital for surgery. Randomization will be performed using computer-generated random number tables in opaque sealed envelopes prepared by an anesthesiologist who will be not part of the study

Patients will be randomly divided into two groups using a computer generated random number chart. Group S received scalp block with 20 ml of 0.5% bupivacaine, whereas Group C received scalp block using 20 mL normal saline and will be considered as control group.

Conditions

Postoperative Nausea and Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Group S

Group S received scalp block with 20 ml of 0.5% bupivacaine

Group Type: EXPERIMENTAL

Scalp block

Intervention Type: PROCEDURE

Patients will be randomly divided into two groups using a computer generated random number chart. Group S received scalp block with 20 ml of 0.5% bupivacaine, whereas Group C will not receive any intervention and will be considered as control group.

Group C

Group C will not have any intervention

Group Type: PLACEBO_COMPARATOR

Control Group

Intervention Type: OTHER

Patients will be randomly divided into two groups using a computer generated random number chart. Group S received scalp block with 20 ml of 0.5% bupivacaine, whereas Group C will not receive any intervention and will be considered as control group.

Interventions

Scalp block

Patients will be randomly divided into two groups using a computer generated random number chart. Group S received scalp block with 20 ml of 0.5% bupivacaine, whereas Group C will not receive any intervention and will be considered as control group.

Intervention Type: PROCEDURE

Control Group

Patients will be randomly divided into two groups using a computer generated random number chart. Group S received scalp block with 20 ml of 0.5% bupivacaine, whereas Group C will not receive any intervention and will be considered as control group.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• ASA I and II patients,
• aged 18 to 50 years,
• 70-80 kg,
• undergoing elective supratentorial craniotomy

Exclusion Criteria

• patients under 18 years of age,
• pregnancy,
• emergency surgery,
• patients with a Glasgow Coma Score (GCS) less than 15,
• those with documented allergy to bupivacaine,
• regular communication not possible,
• Patients requiring prolonged mechanical ventilation (> 2 hours after end of surgery) will be also excluded

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Raham Hasan Mostafa, MD

Assistant Professor of Anesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Raham Hasan Mostafa, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant Lecturer of Anesthesia, Ain Shams University

Locations

Raham Hasan

Cairo, , Egypt

Countries

Egypt

Other Identifiers

R 54/2019

Identifier Type: -

Identifier Source: org_study_id